Mar 22, 2018  |  Posted by: 

The deadline to comply with the EU General Data Protection Regulation (GDPR) is May 25, 2018. Are you ready? For Life Science companies you may be readier than you think. The key is to leverage the controls and practices that you already should have in place.

What is GDPR?

In December 2015 the EU parliament voted to finalize GDPR and set May 25, 2018 as the deadline for compliance. The primary objective of GDPR is to give citizens control...  
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Feb 05, 2018  |  Posted by: 

Data integrity is a critical regulatory requirement for the life science industry that is applicable to validation lifecycle. All information data and records generated during validation and the lifecycle of GMP systems is subject to data integrity regulatory requirements. Data integrity refers to the accuracy and consistency of stored data, indicated by an absence of any alteration in data between two updates of a data record. Data integrity is defi...  
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Jan 17, 2018  |  Posted by: 

Requirements Traceability Matrix is a regulatory requirement for the life science industry. The Requirements Traceability Matrix (RTM) is a document that links requirements throughout the validation process. The purpose of the Requirements Traceability Matrix is to ensure that all requirements defined for a system are tested in the test protocols. The requirements traceability matrix is usually developed in concurrence with the initial list of requir...  
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Nov 20, 2017  |  Posted by: 

Commissioning and Qualification is a critical regulatory requirement for the life sciences industry. The purpose of commissioning and qualification is to ensure and provide documented evidence that facilities and equipment are qualified based on their intended use. Commissioning and qualification typically. includes the following activities and deliverables:
  • Commissioning Plan
  • Basis of Design
  • Syst...  
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Nov 10, 2017  |  Posted by: 

How technology can ensure adherence to regulatory requirements

Two worlds are colliding and it’s very exciting because they promise to give birth to a promising new future. The two worlds are Technology, with blockchain, and Regulatory, with data integrity. Combined the two appear to be the ingredients that, when combined, will solve many problems we face today. First, let’s talk about blockchain, which is a bunch of blocks linked toge...  
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Oct 17, 2017  |  Posted by: 

In 2011, FDA published a new guidance for the industry on Process Validation: General Principles and Practices. This guidance aligns process-validation activities with the product life-cycle concept which moves from the current 3 batch process to a 3-stage process requires significant changes with traditional validation process and approach. Traditional process validation is a paper-based inefficient and time-consuming process. Paper-based process vali...  
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Sep 28, 2017  |  Posted by: 

During the operational phase of Clean In Place (CIP) cycles companies rely in manual methods to determine the success of routine cleaning process. Some of these manual methods to determine the success of the routine cleaning cycles rely on performing very inefficient activities that are very costly and don’t have adequate cycle times. Some of these inefficient methods include the following examples:
Aug 30, 2017  |  Posted by: 

Validation is a global regulatory requirement in the life science industry. The purpose of validation is to establish evidence that systems and processes will consistently yield results that meet predetermined specifications. The goal of the validation process is to ensure that systems and processes work as intended and they meet user requirements. Validation regulatory requirements are driven by regulations such as FDA 21 CFR Part 11, EU Annex 11...  
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